Judge knocks down Gov. Patrick's ban on painkiller Zohydro

A federal judge Tuesday granted a request by a drug manufacturer for an injunction temporarily halting Gov. Deval Patrick's attempt to ban the prescribing of the painkiller Zohydro.

Colleen QuinnState House News Service

BOSTON — A federal judge Tuesday granted a request by a drug manufacturer for an injunction temporarily halting Gov. Deval Patrick’s attempt to ban the prescribing of the painkiller Zohydro.

Zogenix Inc., the marketers of Zohydro ER, had filed a lawsuit in U.S. District Court in Massachusetts arguing that state officials did not have the authority to prohibit sales of a drug approved by the Food and Drug Administration.

Lawyers for the drug company argued the ban was in “direct conflict” with the authority of the FDA to determine for the public if a drug is safe and effective, while lawyers for the state said Patrick was within his rights to act during a public health emergency to limit or ban access to certain drugs.

U.S. District Court Judge Rya Zobel sided against the governor, calling the state’s arguments “without merit” and concluding that Zogenix is “likely to prevail” in the final ruling on the case. The judge’s granting of the injunction does not take effect until April 22.

“When the Commonwealth interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of DPH’s emergency order, did it obstruct the FDA’s Congressionally-given charge? I conclude that it did,” Zobel wrote in her five-page ruling.

She continued, “The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs—here, opioid analgesics. If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health.”

Patrick banned Zohydro ER last month after declaring a public health emergency around the heroin and opioid addiction epidemic in the state. At least 140 have died of heroin overdoses in Massachusetts during the past several months.

Zogenix officials said the judge’s ruling supports “upholding the Constitutional principle at the heart of this case.”

“Allowing states to overturn the decisions of medical and scientific professionals at the FDA, which is the federal agency Congress has authorized to regulate matters involving patient safety and the effectiveness of medications, would set an alarming precedent with respect to the federal regulation of access to new prescription medications,” company officials stated in a release.

“Today’s legal ruling was a positive step forward for Massachusetts patients,” Roger Hawley, chief executive officer of Zogenix said in a statement. “We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment.”

During a press conference on March 27, the governor said he would ban any hydrocodone-only formulation, commonly known as Zohydro, as part of the emergency steps the administration was taking take to combat the drug problem. Patrick said it poses a “significant risk to individuals already addicted to opiates and to the public at large.”

Secretary of Health and Human Service John Polanowicz said Tuesday afternoon he had just learned about the judge’s decision to suspend Patrick’s prohibition of the drug.

“We are going to review the finding,” Polanowicz said.

The drug, approved by the FDA last October, hit the market last month, but no prescriptions have been filled in the state for the painkiller due to Patrick’s ban, according to company officials.

Zogenix officials have said they have taken steps to prevent misuse of Zohydro, and dispute claims that it is more addictive or powerful than other commonly prescribed opioids.

During the federal approval process, some public health officials expressed concerns about the drug’s potency and potential for abuse. Patrick said he would lift the ban if the drug-maker developed a more abuse and tamper resistant formula.

“Imagine 50 states each imposing a different formulation requirement,” Zogenix attorney Stephen Hollman said during a hearing Monday at the John Joseph Moakley U.S. Courthouse.